Comparing Ciprofloxacin (CPFX) With Cefepime (CFPM) in Fe... | NCT00137787

Studies
Comparing Ciprofloxacin (CPFX) With Cefepime (CFPM) in Febrile Neutropenic Patients With Hematologic Diseases

NCT00137787

Sponsor

Center for Supporting Hematology-Oncology Trials

Status

Completed

Last Update Posted

Jun 26, 2018Actual

Enrollment

51Actual

Phase

Phase 3

Conditions

Febrile Neutropenia

Interventions

ciprofloxacin
cefepime

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2005Actual

Primary Completion Date

Dec 2009Actual

Completion Date

May 2010Actual

First Submitted Date

Aug 28, 2005

First Submission Date that Met QC Criteria

Aug 28, 2005

First Posted Date

Aug 30, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 25, 2018

Last Update Posted Date

Jun 26, 2018Actual

Name	Class
Bayer	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this study is to investigate whether intravenous ciprofloxacin is as effective as cefepime for the initial treatment of febrile neutropenia developed in patients with hematologic diseases.

Detailed Description

Infectious complications during neutropenic periods are major causes of morbidity and mortality especially for patients with hematological diseases, and prompt initiation of antibiotic therapy is warranted for those who develop febrile neutropenia. As for initial therapeutic agents, beta-lactam antibiotics, i.e., third- or fourth-generation cephalosporins and carbapenems have been used frequently because of their strong and broad-spectrum of action. However, under these conditions, development of resistance mediated by a beta-lactamase is concerned, and there is a need for alternative non-beta-lactam antibiotics for this indication. Ciprofloxacin is a potent agent covering against wide range of strains including Pseudomonas aeruginosa, and expected as a potential candidate. We have therefore planned a prospective randomized controlled trial designed to compare intravenous ciprofloxacin with cefepime for febrile neutropenic patients.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

51Actual

Label	Type	Description	Intervention Names
1	Experimental		Drug: ciprofloxacin
2	Active Comparator		Drug: cefepime

Name	Type	Description	Arm Group Labels	Other Names
ciprofloxacin	Drug		1
cefepime

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Treatment efficacy		At 7 days after initiating therapy

Secondary Outcomes

Measure	Description	Time Frame
Treatment efficacy		At 21 days
Toxicity		During the follow-up period

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Hematologic disease
Ages between 15 and 79 years
Axillary temperature of 38.0 C or greater on one occasion or of 37.5 to 37.9 C lasting for more than 1 hour
Absolute neutrophil count of less than 500/microL
T-Bil level less than 2.0 times the upper limit of normal
Cre level less than 1.5 times the upper limit of normal
Written informed consent

Exclusion Criteria:

Past history of allergic reaction to the study drug
Positive for HIV antibody
Pregnant or lactating women
Family history of auditory disturbance
Having received systemic antibacterial therapy within 14 days
Receiving systemic antifungal or antiviral therapy except fluconazole or acyclovir for cases undergoing transplantation
No recovery of neutrophil count of 1,000/microL or higher from the previous febrile episode
On treatment with ketoprofen
On treatment with sodium valproate
Septic shock

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

79 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yoshiko Atsuta, MD	Nagoya University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nagoya University Graduate School of Medicine		Nagoya		466-8550	Japan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23317527	Result	Yasuda T, Suzuki R, Ishikawa Y, Terakura S, Inamoto Y, Yanada M, Nagai H, Ozawa Y, Ozeki K, Atsuta Y, Emi N, Naoe T. Randomized controlled trial comparing ciprofloxacin and cefepime in febrile neutropenic patients with hematological malignancies. Int J Infect Dis. 2013 Jun;17(6):e385-90. doi: 10.1016/j.ijid.2012.12.005. Epub 2013 Jan 11.

ID	Term
D009503	Neutropenia
D000380	Agranulocytosis
D007970	Leukopenia
D000095542	Cytopenia

ID	Term
D024841	Fluoroquinolones
D042462	4-Quinolones
D015363	Quinolones
D011804	Quinolines

ID	Term
D064147	Febrile Neutropenia
D006402	Hematologic Diseases